Clontech Laboratories, Inc. v. Invitrogen Corp. (Formerly Life Technologies, Inc.)

406 F.3d 1347, 74 U.S.P.Q. 2d (BNA) 1598, 2005 U.S. App. LEXIS 7767
CourtCourt of Appeals for the Federal Circuit
DecidedMay 5, 2005
Docket2003-1464
StatusPublished
Cited by52 cases

This text of 406 F.3d 1347 (Clontech Laboratories, Inc. v. Invitrogen Corp. (Formerly Life Technologies, Inc.)) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Clontech Laboratories, Inc. v. Invitrogen Corp. (Formerly Life Technologies, Inc.), 406 F.3d 1347, 74 U.S.P.Q. 2d (BNA) 1598, 2005 U.S. App. LEXIS 7767 (Fed. Cir. 2005).

Opinion

CLEVENGER, Circuit Judge.

Invitrogen Corporation appeals the judgment of the United States District Court for the District of Delaware holding that Invitrogen falsely marked certain of its molecular biology products. Clontech Labs., Inc. v. Invitrogen Corp., 263 F.Supp.2d 780 (D.Del.2003). Because the evidence does not support the court’s finding that the relevant tests put Invitrogen on clear notice that certain products were not covered by the patents used to mark those products, we affirm-in-part, reverse-in-part, vacate-in-part, and remand for further proceedings consistent with this opinion.

I

This appeal arises from a 1998 lawsuit filed by Clonteeh Laboratories, Incorporated (“Clonteeh”) against Invitrogen Corporation (“Invitrogen”) (formerly Life Technologies, Incorporated) alleging, inter alia, false marking under 35 U.S.C. § 292. The patents involved in the suit all claim priority to U.S. Patent Application No. 143,396, which was filed on January 13, 1988. The ’396 application was continued as U.S. Patent Application 671,156, filed March 18, 1991, which issued as U.S. Patent No. 5,244,797 (“the ’797 patent”). The 156 application was divided, giving rise to U.S. Patent Application No. 825,260, filed January 24, 1992, which issued as U.S. Patent No. 5,405,776 (“the ’776 patent”). The ’260 application was continued as U.S. Patent Application No. 404,907, filed March 15, 1995, and was again continued as U.S. Patent Application No. 614,260, filed March 12, 1996, which issued as U.S. Patent No. 5,668,005 (“the ’005 patent”). The *1350 614,260 application was continued as U.S. Patent Application No. 798,458, filed February 10, 1997, which issued as U.S. Patent No. 6,063,608 (“the ’608 patent”).

All four patents share the same title: “Cloned Genes Encoding Reverse Tran-scriptase Lacking RNase H Activity.” The claims in all four patents are generally directed to RNase H deficient Reverse Transcriptase (“RT”) polypeptides, see, e.g., the ’797 patent (claim 1), the ’608 patent (claim 1); polynucleotides encoding RT polypeptides, see, e.g., the ’776 patent (claim 1), the ’005 patent (claim 1), the ’608 patent (claim 185); methods of using RTs to prepare DNA molecules, see, e.g., the ’005 patent (claim 8), the ’608 patent (claim 189); and kits for preparing DNA molecules using RTs, see, e.g., the ’005 patent (claim 25), the ’608 patent (claim 195).

Invitrogen markets RNase H deficient RTs known as SUPERSCRIPT (“SS”) and SUPERSCRIPT II (“SSII”). 263 F.Supp.2d at 786. SS and SSII are virally derived RTs either missing sequences important for RNase H activity, e.g., SS, or containing point mutations in regions of the RT coding sequence important for RNase H activity, e.g., SSII. Id. Invitrogen also produces and sells kits containing SSII as well as a wide variety of cDNA libraries purportedly made using SSII. Id. SS and SSII have been marked with all four patents. Id. at 788. In addition, the kits containing SSII and the many cDNA libraries have been marked with some of the patents at issue. See (J.A. at 2742-61).

II

Below, the parties disputed whether In-vitrogen’s SS, SSII, kits, and cDNA library products were falsely marked. In particular, the parties contested whether the patents at issue covered Invitrogen’s many cDNA library products and whether the kits and SUPERSCRIPT products failed to meet the “substantially no RNase H activity” limitation of this family of patents, see, e.g., the ’797 patent (claim 1), the ’776 patent (claims 1 and 5), the ’005 patent (claims 1, 8, 21, 30, and 34), and the alternative language of the most recent family member, the ’608 patent, see, e.g., claim 1 (“substantially reduced RNase H activity”), claim 3 (“no detectable RNase H activity”), claim 24 (“does not significantly degrade an mRNA template”), claim 31 (“no detectable RNase H activity”).

The trial court held that Invitrogen’s SS, SSII, kits, and cDNA library products had been falsely marked with the patents in suit. 263 F.Supp.2d at 793. The trial court determined that “[n]one of Invitro-gen’s patents in suit are directed to cDNA libraries,” id. at 790, and that the claim limitation “substantially no RNase H activity,” as used in this family of patents, was defined in the written description. Id. at 785. Specifically, the court concluded that the written description defines “substantially no RNase H activity” in terms of an assay that measures how active a nearly pure population of RT polypeptides is at cutting RNA:

By the terms ‘substantially no RNase H activity’ is intended reverse transcrip-tase purified to near homogeneity and having an RNase H activity of less than 0.001 pmoles [ 3H](A)„, solubilized per <tg protein with a [ 3H](A)TC.(dT),l substrate in which the [ 3H](A)n [sic] has a specific radioactivity of 2,200 cpm/pmole. RNase H activities of this specific activity or less allows the preparation of cDNA without significant degradation of the mRNA template during first-strand synthesis.

*1351 The ’797 patent, col. 9, 11. 14-22; see also the ’776 patent, col. 9, 11. 14-22; the ’005 patent, col. 9, 11. 19-27; the ’608 patent, col. 9, 11. 21-29. 1 The court did not distinguish between the “substantially no RNase H activity” used in the claims of the ’797,-’776, and ’005 patents and the alternative language used in the claims of the ’608 patent.

Interpreting 35 U.S.C. § 292, the trial court placed the burden on Clontech to prove four elements: “(1) a marking importing that an object is patented (2) falsely affixed to (3) an unpatented article (4) with intent to deceive the public.” 263 F.Supp.2d at 791. Then the court considered these elements in light of evidence pertaining to Invitrogen’s products and patents as well as several RNase H activity experiments performed over the life of this patent family by the inventors and other Invitrogen scientists and experts. Id. at 787-88, 792-93. The evidence included experimental results from solubili-zation and gel assays performed in 1990, 1991, 1996, and 2000. Id. at 787-88. In contrast to the earlier experiments, the 2000 experiments were performed using the solubilization assay defined in the written description for the “express purpose” of determining whether Invitrogen’s SS and SSII meet the limitation of “substantially no RNase H activity.” Deciding that the 2000 experiments were dispositive, the court found that “[a]t the very least, these tests put [Invitrogen] on notice that its products were not covered by the patents in suit and any good faith belief that [Invi-trogen] had that its products were covered by the patents was lost.” Id. at 793. The court reasoned that after this notice, “[In-vitrogen’s] failure to correct its mistaken mismarking of its products rose to the level of deceptive intent.” Id.

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406 F.3d 1347, 74 U.S.P.Q. 2d (BNA) 1598, 2005 U.S. App. LEXIS 7767, Counsel Stack Legal Research, https://law.counselstack.com/opinion/clontech-laboratories-inc-v-invitrogen-corp-formerly-life-cafc-2005.